Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - revinty

Document Subject

Generated Narrative: MedicinalProductDefinition mp3da56d21dbca77ac4fb1bb4e78b231d0

identifier: http://ema.europa.eu/identifier/EU/1/14/929/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Revinty Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed

type: Full name

part

part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-3da56d21dbca77ac4fb1bb4e78b231d0

identifier: http://ema.europa.eu/identifier/EU/1/14/929/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - revinty

Attesters

Step-by-step instructions for use

What is in this leaflet

1. What Revinty Ellipta is and what it is used for
2. What you need to know before you use Revinty Ellipta
3. How to use Revinty Ellipta
4. Possible side effects
5. How to store Revinty Ellipta
6. Contents of the pack and other information

Revinty Ellipta contains two active substances: fluticasone furoate and vilanterol. Two different strengths of Revinty Ellipta are available: fluticasone furoate 92 micrograms/vilanterol 22 micrograms and fluticasone furoate 184 micrograms/vilanterol 22 micrograms.

The 92/22 micrograms strength is used for the regular treatment of chronic obstructive pulmonary disease (COPD) in adults, and asthma in adults and adolescents 12 years and over.

The 184/22 micrograms strength is used to treat asthma in adults and adolescents aged 12 years and older. The 184/22 micrograms strength is not approved for the treatment of COPD.

Revinty Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD and asthma. It should not be used to relieve a sudden attack of breathlessness or wheezing. If you get this sort of attack you must use a quick-acting inhaler (such as salbutamol). If you do not have a quick-acting inhaler contact your doctor.

Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids. Corticosteroids reduce inflammation. They reduce the swelling and irritation in the small air passages in the lungs and so gradually ease breathing problems. Corticosteroids also help to prevent attacks of asthma and aggravation of COPD.

Vilanterol belongs to a group of medicines called long acting bronchodilators. It relaxes the muscles of the small air passages in the lungs. This helps to open the airways and makes it easier for air to get in and out of the lungs. When it is taken regularly, it helps the small air passages to remain open.

When you take these two active substances together regularly, they will help to control your breathing difficulties more than either medicine alone. Asthma is a serious, long term lung disease where the muscles surrounding the smaller airways become tight (bronchoconstriction) and swollen and irritated (inflammation). Symptoms come and go and include shortness of breath, wheezing, chest tightness and cough. Revinty Ellipta has been shown to reduce flare-ups and symptoms of asthma.

Chronic obstructive pulmonary disease (COPD) is a serious, long term lung disease where the airways become inflamed and thickened. Symptoms include shortness of breath, cough, chest discomfort and coughing up mucus. Revinty Ellipta has been shown to reduce flare-ups of COPD symptoms.

Do not use Revinty Ellipta

• if you are allergic to fluticasone furoate, vilanterol or any other ingredients of this medicine (listed in section 6).
• if you think the above applies to you, do not use Revinty Ellipta until you have checked with your doctor.

Warnings and precautions Talk to your doctor before using Revinty Ellipta: -if you have liver disease, as you may be more likely to have side effects. If you have moderate or severe liver disease, your doctor will limit your dose to the lower strength of Revinty Ellipta (92/22 micrograms once daily). -if you have heart problems or high blood pressure. -if you have tuberculosis (TB) of the lung, or any long standing or untreated infections. -if you have ever been told you have diabetes or high blood sugar. -if you have thyroid gland problems. -if you have low potassium in your blood. -if you experience blurred vision or other visual disturbances.

Check with your doctor before you use this medicine if you think any of these applies to you.

While youare using Revinty Ellipta

Immediate breathing difficulties If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Revinty Ellipta inhaler: stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.

• Contact your doctor if you experience blurred vision or other visual disturbances.
• Contact your doctor if you experience increased thirst, frequent urination or unexplained tiredness (signs of high blood sugar).

Infection of the lung If you are using this medicine for COPD you may be at an increased risk of developing an infection of the lungs known as pneumonia. See section 4 for information on symptoms to look out for while you are using this medicine. Tell your doctor as soon as possible if you develop any of these symptoms.

Children and adolescents Do not give this medicine to children under the age of 12 years for the treatment of asthma, or in children and adolescents of any age for the treatment of COPD. Other medicines and Revinty Ellipta Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicinesn. If you are not sure what your medicine contains talk to your doctor or pharmacist.

Some medicines may affect how this medicine works, or make it more likely that you will have side effects. These include:

• medicines called beta-blockers, such as metoprolol, used to treat high blood pressure or a heart problems.
• ketoconazole, to treat fungal infections.
• ritonavir or cobicistat, to treat HIV infections.
• long-acting beta2-adrenergic agonists, such as salmeterol

Tell your doctor or pharmacist if you are taking any of these medicines. Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Revinty Ellipta.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not use this medicine if you are pregnant unless your doctor tells you that you can.

It is not known whether the ingredients of this medicine can pass into breast milk. If you are breast- feeding, you must check with your doctor before you use Revinty Ellipta. Do not use this medicine if you are breast-feeding unless your doctor tells you that you can.

Driving and using machines
This medicine is unlikely to affect your ability to drive or use machines.

Revinty Ellipta contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact to your doctor before using this medicine.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Asthma The recommended dose to treat asthma is one inhalation (92 micrograms of fluticasone furoate and 22 micrograms of vilanterol) once daily at the same time each day.

If you have severe asthma, your doctor may decide that you should use one inhalation of the higher strength inhaler (184 micrograms fluticasone furoate and 22 micrograms of vilanterol). This dose is also used once daily at the same time each day.

COPD The recommended dose to treat COPD is one inhalation (92 micrograms of fluticasone furoate and 22 micrograms of vilanterol) once daily at the same time each day.

The higher strength of Revinty Ellipta (184 micrograms fluticasone furoate and 22 micrograms of vilanterol) is not suitable for the treatment of COPD.

Revinty Ellipta is for oral inhalation. Use Revinty Ellipta at the same time each day as it is effective over 24 hours
It is very important that you use this medicine every day, as instructed by your doctor. This will help to keep you free of symptoms throughout the day and night.

Revinty Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing. If you get this sort of attack you must use a quick-acting inhaler (such as salbutamol).

If you feel you are getting breathless or wheezy more often than normal, or if you are using your quick-acting inhaler more than usual, see your doctor.

How to use Revinty Ellipta
See Step-by-step instructions for use after section 6 of this leaflet for full information.

Revinty Ellipta is for oral inhalation. You do not need to prepare Revinty Ellipta in any special way, not even the first time you use it.

If your symptoms do not improve If your symptoms (breathlessness, wheezing, cough) do not improve or get worse, or if you are using your quick-acting inhaler more often:
contact your doctor as soon as possible.

If you use more Revinty Ellipta than you should
If you accidentally use more Revinty Ellipta than your doctor has instructed, talk to your doctor or pharmacist. If possible, show them the inhaler, the package or this leaflet. You may notice that your heart is beating faster than usual, you feel shaky or have a headache.

If you have used more than instructed for a long period of time, it is particularly important that you ask your doctor or pharmacist for advice. This is because larger doses of Revinty Ellipta may reduce the amount of steroid hormones produced naturally by your body.

If you forget to use Revinty Ellipta
Do not inhale a double dose to make up for a forgotten dose. Just take your next dose at the usual time.

If you become wheezy or breathless, or develop any other symptoms of an asthma attack, use your quick-acting inhaler (e.g. salbutamol), then seek medical advice.

Do not stop using Revinty Ellipta without advice
Use this medicine for as long as your doctor recommends. It will only be effective as long as you are using it. Do not stop unless your doctor advises you to, even if you feel better.

If you have further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic Reactions

Allergic reactions are rare (may affect up to 1 in 1,000 people).
If you have any of the following symptoms after taking Revinty Ellipta stop taking this medicine and tell your doctor immediately. skin rash (hives) or redness
swelling, sometimes of the face or mouth (angioedema) becoming very wheezy, coughing or having difficulty in breathing suddenly feeling weak or light headed (which may lead to collapse or loss of consciousness).

Immediate breathing difficulties

Immediate breathing difficulties after using Revinty Ellipta are rare. If your breathing or wheezing gets worse straight after using this medicine, stop using it and get medical help immediately.

Pneumonia (infection of the lung) (common side effect, may affect up to 1 in 10 people) Tell your doctor if you have any of the following while taking Revinty Ellipta they could be symptoms of a lung infection:
fever or chills increased mucus production, change in mucus colour increased cough or increased breathing difficulties.

Other side effects:

Very common side effects These may affect more than 1 in 10 people: headache common cold.

Common side effects
These may affect up to 1 in 10 people:
sore, raised patches in the mouth or throat caused by a fungal infection (candidiasis). Rinsing your mouth out with water immediately after using Revinty Ellipta may help stop this side effect developing. inflammation of the lungs (bronchitis) infection of the nose sinuses or throat flu (influenza)
pain and irritation in the back of the mouth and throat inflammation of the sinuses itchy, runny or blocked nose
cough voice disorders weakening of the bones, leading to fractures stomach pain
back pain high temperature (fever) joint pain muscle spasms.

Uncommon side effects
This may affect up to 1 in 100 people:
irregular heartbeat
blurred vision increase in blood sugar (hyperglycaemia).

Rare side effects These may affect up to 1 in 1,000 people:
heart beating faster (tachycardia) awareness of heart beat (palpitations) tremor anxiety.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, tray and inhaler after EXP. The expiry date refers to the last day of that month.

Keep the inhaler inside the sealed tray to protect from moisture and only remove immediately before first use. Once the tray is opened, the inhaler can be used for up to 6 weeks, starting from the date of opening the tray. Write the date the inhaler should be thrown away on the label in the space provided. The date should be added as soon as the inhaler has been removed from the tray.

Do not store above 25 C.

If stored in a refrigerator, allow the inhaler to return to room temperature for at least an hour before use.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Revinty Ellipta contains

• The active substances are fluticasone furoate and vilanterol.
• For the 92/22 mcg dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
• For the 184/22 mcg dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
• The other ingredients are lactose monohydrate (See section 2 under Revinty Ellipta contains lactose ) and magnesium stearate.

What Revinty Ellipta looks like and contents of the pack
Revinty Ellipta is an inhalation powder, pre-dispensed.
The Ellipta inhaler consists of a light grey inhaler with a yellow mouthpiece cover and a dose counter. It is packaged in a foil laminate tray with a peelable foil lid. The tray contains a desiccant sachet, to reduce moisture in the packaging. Once you have opened the lid of the tray, throw the desiccant away do not eat or inhale it. The inhaler does not need to be stored in the foil laminate tray once it has been opened.
Revinty Ellipta is available in packs of 1 inhaler containing either 14 or 30 doses (14 or 30 day supply) and in multipacks containing 90 (3 inhalers of 30) doses (90 day supply). Not all pack sizes may be marketed.

Marketing Authorisation Holder:

GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus Dublin Ireland

Manufacturer:

Glaxo Wellcome Production Zone Industrielle No.2 23 Rue Lavoisier
27000 Evreux
France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v. T l/Tel: + 32 (0) 10 85 52 Lietuva UAB BERLIN-CHEMIE MENARINI BALTIC
Tel: +370 52 691 lt@berlin-chemie.com

• / .
  E
  Te .: +359 2 454 0bcsofia@berlin-chemie.com

Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique/Belgien T l/Tel: + 32 (0) 10 85 52 esk republika GlaxoSmithKline s.r.o. Tel: + 420 222 001 cz.info@gsk.com Magyarorsz g Berlin-Chemie/A. Menarini Kft. Tel.: +36 23501bc-hu@berlin-chemie.com

Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 dk-info@gsk.com

Malta GlaxoSmithKline (Ireland) Limited
Tel: +356 80065Deutschland BERLIN-CHEMIE AG Tel.: +49 (0) 30 67Nederland GlaxoSmithKline BV Tel: + 31 (0) 33 2081Eesti O Berlin-Chemie Menarini Eesti
Tel: +372 667 5ee@berlin-chemie.com

Norge GlaxoSmithKline AS Tlf: + 47 22 70 20
Guidotti Hellas A.E. : +30 210 8316111- sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com

Espa a FAES FARMA, S.A. Tel: + 34 900 460 aweber@faes.es

Polska GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9France MENARINI France T l.: + 33 (0)1 45 60 77 Portugal BIAL, Portela & Ca. SA. Tel: + 351 22 986 61 info@bial.com

Hrvatska Berlin-Chemie Menarini Hrvatska d.o.o. Tel: +385 1 4821 office-croatia@berlin-chemie.com

Rom nia GlaxoSmithKline (Ireland) Limited
Tel: +40 800672Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955Slovenija Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o.
Tel: +386 (0)1 300 2slovenia@berlin-chemie.com

sland Vistor hf. S mi: + 354 535 7Slovensk republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o. Tel: +421 2 544 30 slovakia@berlin-chemie.com

Italia A. Menarini Industrie Farmaceutiche Riunite s.r.l. Tel: +39-055 56Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30
GlaxoSmithKline (Ireland) Limited
: +357 80070Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 info.produkt@gsk.com

Latvija SIA Berlin-Chemie/Menarini Baltic
Tel: +371 67103lv@berlin-chemie.com United Kingdom (Northern Ireland) GlaxoSmithKline (Ireland) Limited Tel: + 44 (0)800 221customercontactuk@gsk.com

This leaflet was last revised in <{MM/YYYY}>

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: